Suture passing instrument and method

ABSTRACT

In one embodiment, a continuous suture passer device may include a first jaw, a second jaw, a tissue penetrator which may penetrate through tissue positioned between the first and second jaws, and a suture shuttle which may be releasably secured to the tissue penetrator and adapted to carry a suture. Further, the device may include an actuator which may manipulate at least one of the first or second jaws and the tissue penetrator, and the second jaw may have a suture shuttle retainer seat on which the suture shuttle may be releasably secured. The tissue penetrator may be movable towards the second jaw such that the suture shuttle carried by the tissue penetrator may be transferred to the shuttle retainer seat on the second jaw. Additionally, the first and second jaws may be substantially parallel to one another at any position to which the at least one jaw is manipulated. Additionally, the tissue penetrator may travel along an arcuate path from a first position, recessed within the first jaw, to a second position where the tissue penetrator extends through the tissue to be positioned in communication with the second jaw. Further, the at least one jaw may be manipulated such that it travels along a path that is substantially the same arcuate path traveled by the tissue penetrator. A method for passing a suture through tissue includes manipulation to transfer a suture shuttle adapted to carry a suture between a tissue penetrator and a second jaw.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of the filing dates of U.S.Provisional Patent Application Nos. 60/985,543 filed Nov. 5, 2007;60/985,556 filed Nov. 5, 2007; 61/013,989 filed Dec. 14, 2007;61/013,994 filed Dec. 14, 2007; 61/014,728 filed Dec. 18, 2007;61/013,999 filed Dec. 14, 2007; 61/014,003 filed Dec. 14, 2007;61/014,012 filed Dec. 14, 2007; 61/042,678 filed Apr. 4, 2008; and61/127,658 filed May 14, 2008, the disclosures of each of the foregoingbeing incorporated herein by reference as if fully set forth herein.

BACKGROUND OF THE INVENTION

This invention relates to surgical stitching devices by which a stitchor continuous stitches may be made during surgery.

Suturing instruments for assisting a medical practitioner in placingstitches during surgical procedures are particularly helpful in surgicalprocedures requiring the placement of secure and accurate sutures indifficult to access regions of the body. Instruments and methods forsuturing remotely are especially important in minimally invasivesurgical procedures such as laparoscopic and endoscopic procedures. Inaddition to helping to access remote regions of the body requiringsuturing, suturing instruments may also allow the efficient manipulationof very small needles and the formation of small and precise sutures.

Arthroscopic rotator cuff repair is one example of a technicallychallenging procedure that requires the placement of sutures indifficult to reach regions, as well as requiring precise placement ofsutures. The procedure may be performed with the patient under generalanesthesia, and small (e.g., 5 mm) incisions may be created in the back,side, and front of the shoulder, and an arthroscope and instruments maybe switched between each of these positions as necessary. The rotatorcuff tear may be visualized, and the size and pattern of the tearassessed. Thin or fragmented portions are removed and the area where thetendon will be reattached to the bone is lightly debrided to encouragenew blood vessel ingrowth for healing. Sutures may be placed to close atear. Depending on the size and location of the tear, multiple suturestitches may be required. In many situations, an arthroscopic stitchpasser and grasper are used to pass a suture through the tendon. Astitch passer and grabber are typically only capable of making a singlestitch, and must be withdrawn and reloaded in order to make multiplestitches. Similarly, a separate arthroscopic knot tying instrument istypically used to pass and tie knots in the suture to secure the repair.Furthermore, most currently available suturing instruments are limitedin their ability to be maneuvered, particularly over thicker tissueregions, and may require additional space so that additional surgicalinstruments, including forceps or other graspers, may be used.

For example, the ArthroSew™, USS Sports Medicine, manufactured byCovidien AG, is a bi-directional suturing device with multiple-passcapability that has two jaws hinged to open V-like (from a commonpivot). A suture is attached to the center of a double-ended needlewhich is passed between the two jaws during the stitching process. Atleast one end of the needle protrudes from one or the other jaw at alltimes. The protruding needle may become caught in tissue, a problem thatis exacerbated in difficult to access regions and regions offeringlimited maneuverability, such as the subacromial space of the jaw.

Other continuous suture passers include rotating suture passers, inwhich a curved suture needle is driven about an axis through successiverevolutions to pass through an adjacent tissue, forming a spiral stitchthrough the tissue.

U.S. patent application Ser. No. 11/773,388, titled “METHODS AND DEVICESFOR CONTINUOUS SUTURE PASSING”, and herein incorporated by reference inits entirety as if fully set forth herein, describes devices and methodsfor continuous suture passing.

SUMMARY OF THE INVENTION

The devices described herein include continuous suture passer devicesand components for continuous suture passing. The devices describedherein may include shuttles to which a suture may be attached directlyor using an additional clip, for securing a suture when used with acontinuous suture passer device. Although, in general, continuous suturepassers are capable of passing a suture through a tissue multiple timeswithout having to remove and reload the device, the devices and methodsdescribed herein may also be used to pass a suture a single time. Inparticular, described herein are improved continuous suture passers,particularly suture passers having jaws that open and close in parallel,and that are capable of passing a suture when the jaws are open in anyposition. Any of the devices described herein may be used for continuousstitching and/or knot tying.

In particular, described herein are enhanced devices for continuous (orsingle) suture passing using a shuttle, the device may include elementssuch as shuttles, tissue penetrators, shuttles having suture attachers,and shuttle retainer seats. Also described herein are methods oftreating tissue using a continuous suture passer, which may include someembodiments of suture passers having jaws that open and closesubstantially parallel to each other, and that are capable of passing asuture and/or shuttle when the jaws are in any position.

In operation, a suture is passed from the first jaw to the second jawand/or back from the second jaw to the first jaw. This may beaccomplished using an extendable tissue penetrator that is connected tothe first jaw. The extendable tissue penetrator can pierce the tissue,and may also engage a suture shuttle (to which a suture may be attached)and thereby pull the suture shuttle through the passage that the tissuepenetrator forms in the tissue. Extending the tissue penetrator forms apassage through the tissue, and can also pass the suture between thefirst and second jaws. For example, the tissue penetrator may include asuture shuttle engagement region, such as, in a cavity within the tissuepenetrator, along the outside of the tissue penetrator, or the like, towhich the suture shuttle can be releasably attached. The suture can bepassed from the tissue penetrator in the first jaw to or from a shuttleretainer seat connected to the second jaw. Thus, both the tissuepenetrator and the shuttle retainer seat are configured to releasablysecure the suture and suture shuttle. In some variations, the suturepasser may pass a suture that is not attached to a suture shuttle. Forexample, the suture may be knotted, and the knot may be removably heldby each jaw of the device.

In one embodiment, a continuous suture passer device may include a firstjaw, a second jaw, a tissue penetrator which may penetrate throughtissue positioned between the first and second jaws, and a sutureshuttle which may be releasably secured to the tissue penetrator andadapted to carry a suture. Further, the device may include an actuatorwhich may manipulate at least one of the first or second jaws and thetissue penetrator, and the second jaw may have a suture shuttle retainerseat on which the suture shuttle may be releasably secured. The tissuepenetrator may be movable towards the second jaw such that the sutureshuttle carried by the tissue penetrator may be transferred to theshuttle retainer seat on the second jaw. Additionally, the first andsecond jaws may be substantially parallel to one another at any positionto which the at least one jaw is manipulated.

In another embodiment, a continuous suture passer device may include afirst jaw and a second jaw; an actuator including a jaw control whichmay manipulate at least one jaw; and a tissue penetrator which may beconfigured to travel along an arcuate pathway from the first jaw to thesecond jaw. Further, the first and second jaws may be substantiallyparallel to one another at any position to which the at least one jaw ismanipulated, and wherein the at least one jaw may be manipulated suchthat it travels along a path that is substantially the same arcuate pathtraveled by the tissue penetrator.

In yet another embodiment, a method of passing a suture may includepositioning a tissue between a first jaw and a second jaw of a suturepasser device, wherein the suture passer includes an arcuate extendabletissue penetrator connected with the first jaw and a shuttle retainerseat which may be connected with the second jaw, wherein a sutureshuttle may be releasably held by either the shuttle retainer seat orthe tissue penetrator; manipulating at least one of the first jaw andsecond jaw to secure tissue between them; extending the tissuepenetrator through the tissue from a retracted position in the firstjaw; transferring the suture shuttle between the shuttle retainer seatand the tissue penetrator; and retracting the tissue penetrator throughthe tissue and back into the first jaw. Further, the first jaw andsecond jaw may remain parallel throughout the manipulation.

In a further embodiment, a suture passer device may include a first jawand a second jaw and a tissue penetrator configured to extend from thefirst jaw. The device may further include an actuator including a jawmotion control configured to control the motion of the first and secondjaws so that at least one of the jaws extends or retracts so that thetissue penetrator extending from the first jaw will contact the secondjaw regardless of the position of the at least one jaw. The device mayalso include a tissue penetrator control configured to extend andretract the tissue penetrator from the first jaw, such that the tissuepenetrator control may operate independently of the jaw motion controllayer. Additionally, the device may include a retainer pin control whichmay control a retainer pin, located in the second jaw, independently ofthe jaw motion control or the tissue penetrator control.

Additionally, the tissue penetrator control may include an alternatingstroke limiter, or bi-modal limiter, to alternately pull on a capstan,which may be connected to the retainer pin. Moreover, the tissuepenetrator control and retaining pin control may operate independently,but using a single trigger which may include two pivot points: a fixedpivot point and a pin and slot interface which may be a moving pivot.The jaw motion control may include a lock, such as a ratchet mechanismto secure the at least one jaw in place relative to the other jaw.

Described herein are devices and subassemblies for controlling theopening and closing of a pair of jaws of a suture passer device so thatthe jaws open and close in parallel in a tightly regulated manner,thereby allowing passage of a tissue penetrator from a first jaw so thatthe tissue penetrator contacts a predetermined target position on thesecond jaw regardless of the relative positions of the jaws. The devicesdescribed herein may include multiple control layers to accomplish thecontrolled motion. For example, the devices may include a conjugatemotion layer having a conjugate motion cam surface, and a tissuepenetrator control layer controlling the extension and retraction of thetissue penetrator. In some variations the devices also include aretainer controller layer controls the retention of a suture shuttle.Each of these layers may operate independently of each other. Forexample, the conjugate motion layer may operate to open and close thejaws independently of the tissue penetrator control layer. Features ofthe tissue control layer may interact with features of the conjugatemotion layer.

The methods of passing a suture described herein may be used to formvirtually any number of suture stitches that require multiple passes ofthe suture through tissue. For example, a modified Mason-Allen stitchmay be particularly useful for orthopedic and other applications and maybe formed by the methods described herein, using the continuous suturepassers. The methods described herein may be used as part of anyappropriate medical procedure, including (but not limited to)arthroscopic and endoscopic procedures. For example, the methodsdescribed herein may be used as part of an orthopedic procedure, such asrotator cuff tendon repair, labral tissue repair, capsular tissuerepair, or the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a first embodiment suture passerdevice.

FIG. 1B illustrates a planar view of the suture passer device of FIG.1A.

FIG. 2 illustrates a cross-sectional view of one embodiment of thesuture passer device.

FIG. 3 illustrates a cross-sectional view of the distal end of oneembodiment of the suture passer device.

FIG. 4 illustrates a close-up, perspective view of the distal end of oneembodiment of the suture passer device, wherein the upper jaw istransparent.

FIGS. 5A and 5B illustrate one embodiment of a suture shuttle.

FIGS. 6A and 6B illustrate another embodiment of the suture shuttle.

FIG. 7 illustrates yet another embodiment of the suture shuttle.

FIG. 8 illustrates one embodiment of a tissue penetrator.

FIGS. 9A-9D illustrate one embodiment of the interaction between thesuture shuttle and the tissue penetrator.

FIG. 10 illustrates a first embodiment of a suture clip.

FIGS. 11A-B illustrate another embodiment of the suture clip, split intotwo pieces.

FIG. 12 illustrates the suture clip of FIGS. 11A-B, but combined to formthe complete suture clip.

FIG. 13A-13B illustrates another embodiment of the suture clip.

FIG. 14 illustrates yet a further embodiment of the suture clip.

FIG. 15 illustrates the suture clip of FIG. 14 in use with a suture andsuture passer device.

FIG. 16 illustrates another embodiment of a suture linkage wherein thelinkage forms a FIG. 8.

FIGS. 17A-17B illustrates a first embodiment of the shuttle retainerseat.

FIG. 18 illustrates a second embodiment of the shuttle retainer seat.

FIG. 19 illustrates one embodiment of the interaction of the sutureshuttle and shuttle retainer seat.

FIGS. 20A-20B illustrate, in cross-section of a lower jaw, oneembodiment of the interaction of the suture shuttle, shuttle retainerseat, and a retaining pin.

FIG. 21 illustrates, in cross-section of a lower jaw, one embodiment ofthe interaction of the suture shuttle, shuttle retaining seat, tissuepenetrator, and retaining pin.

FIG. 22 illustrates a further embodiment of a shuttle retainer seatwithin the jaw.

FIG. 23 illustrates, in cross-section of a lower jaw, one embodiment ofa retaining pin, including a spring.

FIG. 24 illustrates another embodiment of a suture shuttle.

FIG. 25 is a close-up cross-section illustrating the interaction of aretaining pin, shuttle retainer seat, tissue penetrator and lower jaw.

FIG. 26 is a top plan view of one embodiment of a lower jaw and shuttleretainer seat.

FIG. 27 is a perspective view of a further embodiment of a lower jaw.

FIG. 28 illustrates a top plan view of a lower jaw wherein oneembodiment of the shuttle retainer seat and stiff member is positioned.

FIGS. 29A-29K illustrate an embodiment of the interaction of theshuttle, shuttle retainer seat, retainer pin and tissue penetrator asthe shuttle is passed between the shuttle retainer seat, the tissuepenetrator, and back again.

FIGS. 30A-30B illustrate one embodiment of a distal portion of a suturepasser device including first and second jaws.

FIG. 31 illustrates another embodiment of a distal portion of a suturepasser device.

FIGS. 32A-32C show yet another embodiment of a distal portion of asuture passer device.

FIG. 33 illustrates a first embodiment of a jaw control mechanism.

FIGS. 34A-34C illustrate another embodiment of a jaw control mechanism.

FIGS. 35A-35B illustrate a first embodiment of a tissue penetratorcontrol mechanism.

FIGS. 36A-36B illustrate further features of the first embodiment tissuepenetrator control mechanism of FIGS. 34A-34B.

FIGS. 37A-37C illustrate one embodiment of retainer pin control layer.

FIGS. 38A-38C illustrate the interaction between one embodiment of thetissue penetrator control layer and one embodiment of the jaw controllayer.

FIGS. 39A-39B illustrate further detail of retainer pin control layer,specifically the communication from the actuator control to retainerpin.

FIGS. 40A-42B illustrate the interaction of one embodiment of the tissuepenetrator control layer and one embodiment of the retainer pin controllayer.

FIGS. 43A-43D illustrate further detail of one embodiment of the slideblock of FIGS. 40A-42B.

FIG. 44 illustrates one embodiment of a shuttleless suture passerdevice.

FIG. 45 illustrates a further embodiment of a tissue penetrator and atleast one of a shuttle and a suture.

FIG. 46 illustrates a further embodiment of a shuttle retaining deviceon a tissue penetrator.

FIG. 47 illustrates one position in which the shuttle retaining deviceof FIG. 46 may be placed on the tissue penetrator.

FIG. 48 illustrates the interaction of the suture shuttle, tissuepenetrator and shuttle retaining device of FIG. 45.

FIG. 49 illustrates one example of meniscus surgery using the suturepasser device of the present invention.

FIGS. 50A-50D illustrate yet another embodiment of meniscus surgery,whereby suture is passed from an anteromedial or anterolateral portalusing the suture passer device of the present invention.

FIG. 51 illustrates one example of anterior cruciate ligament surgeryusing the suture passer device of the present invention.

FIG. 52 illustrates one example of Achilles tendon repair using thesuture passer device of the present invention.

FIGS. 53A-53C illustrates one example of a superior labrum anteriorposterior repair using the suture passer device of the presentinvention.

FIG. 54 illustrates one example of labral repair using the suture passerdevice of the present invention.

FIGS. 55A-55E illustrate a modified Masson-Allen Double Row suture knotfor rotator cuff repair using the suture passer device of the presentinvention.

FIGS. 56A-56C illustrate a further step, following FIGS. 55A-55E, inwhich the remaining strands of suture are tied to at least one knotlesssuture anchor.

FIGS. 57A-57C illustrate one example of a dural tear repair using thesuture passer device of the present invention.

FIG. 58 illustrates one example of an annulus repair using the suturepasser device of the present invention.

DETAILED DESCRIPTION

Described herein are various embodiments of suture passers for passing asuture through tissue, and components of suture passers thatparticularly enhance use. In general, the suture passers describedherein are continuous suture passers that are configured to pass asuture back and forth through a tissue without having to reload thedevice. Thus, these devices may be used for continuous stitching oftissue.

FIG. 1A illustrates a first embodiment of a continuous suture passer 10,including some of the enhanced features described herein, which mayinclude, but is in no way limited to, a tissue penetrator (not shown),shuttle (not shown), reciprocating parallel-opening first and secondjaws 20 and 21, jaw lock (not shown), and lower-jaw shuttle retainerseat 25. FIG. 1B shows a planar view of the device 10, including theparallel-opening jaws 20 and 21, tissue penetrator 50, and lower-jawshuttle retainer seat 25.

FIG. 2 illustrates a cross-sectional view of a first embodiment device10. An actuator portion 15 of device 10 may include the mechanicalelements which operate the entire device 10. For example, the actuator15 includes mechanical elements for movement of at least one of the jaws20 and 21, movement of the tissue penetrator 50, and retainer pin 30(not shown), and associated equipment. Actuator 15 may be, in oneembodiment, a handle. However, actuator 15 could also be any other typeof mechanism to interface the device 10 with a user, such as, a keyboardor remote control for electronic embodiments of the device 10.

FIGS. 3 and 4 show enlarged sectional views of the distal end of device10. In FIG. 3, one embodiment of the distal portion of device 10 isshown in cross-section. Tissue penetrator 50 is retracted within upperjaw 20, and shuttle retainer seat 25 is positioned near the distal endof lower jaw 21. Tissue penetrator 50 may move from a retractedposition, as shown, to an extended position whereby tissue penetrator 50may move out of the distal end of upper jaw 20 and towards lower jaw 21and shuttle retainer seat 25.

FIG. 4 illustrates another embodiment of the relationship of tissuepenetrator 50 with a shuttle 70. The upper jaw 20 is shown astranslucent to uncover detail of tissue penetrator 50 and shuttle 70.Shuttle 70 engages the tissue penetrator such that it can extend fromupper jaw 20 along with tissue penetrator 50 towards lower jaw 21 andshuttle retainer seat 25.

FIGS. 5A-7 illustrate various embodiments of shuttle 70, 170 and 270.Shuttle 70, 170 and 270 may be any shape such that it may be releasablyattached to tissue penetrator 50. While the shape of shuttle 70, 170 and270 may correspond to the shape of at least a portion of the tissuepenetrator 50 for attachment purposes, it may be of any suitable shape.In these illustrative examples, the shuttle is generally triangular inshape, which may correspond to a tissue penetrator 50 having a generallytriangular cross-sectional shape. The illustrated examples of sutureshuttles are “channel shuttles” which may engage a tissue penetrator 50.For example, a triangular or cylindrical tissue penetrator 50 may beused, as illustrated in FIGS. 8-9D, to which the suture shuttle 70, 170and 270 is adapted to connect. Tissue penetrator 50 may be, for example,a needle or any like instrument capable of puncturing through tissue.Shuttle 70, 170 and 270 may be substantially hollow within thetriangular shape, and may further have a channel 71, 171 and 271, oropening, along a portion of the triangular body. This channel 71, 171 or271 may serve as an entry way for tissue penetrator 50 to engage theshuttle 70, 170 and 270. Thus, in these embodiments, the shuttle 70, 170and 270 wraps around a portion of the tissue penetrator 50, which ispositioned within the body of the shuttle.

For example, in FIGS. 5A-B, the channel 71 may be positioned on anyportion of the shuttle 70. In the illustrated examples, the channel ispositioned along an apex of the triangular shape. However, a channel mayalso be placed along a side of triangular shape or in any otherappropriate place.

Some embodiments of shuttle 170, 270 may also contain openings 74 whichmay make the shuttle lighter, and may also facilitate flexing of theshuttle so that it can readily attach/detach from the tissue penetrator50. Further, opening 74 may provide an area through which a retainingmechanism, such as a retainer pin 30, may pass to secure shuttle 170,270.

Some embodiments of shuttle 70, 170 of the present invention may includeadditional features which may provide controllable, positive, robust,repeatable, and manufacturable retaining structures. Such features mayinclude, for example, protrusions, such as dimples 72, 172 or the like,and finger springs 175 a and b, both of which may help to retain shuttle170 on the tissue penetrator 50.

The protruding dimples 72, 172 may interact with divots 52, 152 locatedwithin a cut-out 51, 151, or recessed portion, of the tissue penetrator50. The dimples 72, 172 allow for controllable, repeatable retaining ofthe shuttle 70, 170 on the tissue penetrator 50, whereby the shuttlemay, in a preferred embodiment, snap on and off the tissue penetratorrepeatedly, as necessary. In a preferred embodiment, the position ofshuttle 70, 170 on the tissue penetrator 50 may be the same given anadditional feature such as the dimples and divots. In an alternativeembodiment, dimples 72, 172 may be located on the tissue penetrator 50,while the divots 52, 152 may be located on the suture shuttle 70, 170.

In a further embodiment, the cut-out 51, in FIGS. 8-9D, may beconfigured to seat the shuttle against the outer surface of the tissuepenetrator, thereby allowing the tissue penetrator to present a uniformouter surface as it penetrates the tissue; meaning the shuttle does not“stick out” from the tissue penetrator, but is flush with the outersurface of the tissue penetrator. This helps keep the shuttle on thetissue penetrator as it extends from upper jaw 20 and penetrates tissue.

Additionally, in yet a further embodiment, the upper edge 54 of tissuepenetrator 50 may be sharpened to provide additional cutting surface ontissue penetrator. In this variation, the shuttle 70 should not interactwith the upper edge 54 such that upper edge 54 is exposed to assist inthe piercing action of tissue penetrator.

In a further preferred embodiment, tissue penetrator 50 may include anadditional cut-out 51′ along a portion of tissue penetrator 50 withincut-out 51. Cut-out 51′ may allow additional room for a linkage 85 (seeFIG. 15, for example). Cut-out 51′ may reduce the chance of damage tolinkage 85 during tissue penetrator 50 insertion into shuttle 70, sincecut-out 51′ may provide additional clearance for linkage 85.

In one embodiment, for example in FIGS. 6A-B and 9A-D, finger springs175 a and 175 b may interact with a ramp 153 within the cut-out 151 ofthe tissue penetrator 150. The finger springs, and even the entire sidesof the shuttle 170, may be sloped inwardly towards one end of theshuttle. Thus, in this embodiment, the finger springs are located at thenarrowest portion of the shuttle. This slope of the finger springs mayinteract with the slope of the ramp 153 of the cut-out portion 151. Theinteraction of these two slopes may regulate the holding force of theshuttle 170 on the tissue penetrator 150 prior to the dimples 172interacting with the divots 152 to firmly secure the shuttle to thetissue penetrator. Likewise, the holding force is regulated as theshuttle is removed from the tissue penetrator in a similar manner. Thus,when a force is applied to shuttle 170 to pull shuttle 170 off tissuepenetrator 150, the finger springs may be forced along the ramp, towardsthe tip of tissue penetrator, to engage the ramp, causing the fingersprings, and thus the sides of the shuttle, to flex apart from oneanother, and disengage the dimples from the divots.

Continuing with this embodiment, in FIG. 9A, for example, the dimple 172of the shuttle is engaged with the divot 152 on the tissue penetrator150. At this point, the finger springs may only be slightly engaged tothe tissue penetrator. FIG. 9B illustrates the shuttle 170 beginning tobe removed from tissue penetrator. The dimple is no longer in the divotand is instead moving along the surface of the tissue penetrator. Thefinger springs 175 a are increasingly engaged onto the tissue penetratoras they move along ramp 153 within cut-out on tissue penetrator. In FIG.9C, the finger springs are shown as fully engaged with tissuepenetrator, particularly at the point where the ramp ends (at the distalend of cut-out portion). This full engagement may, in a preferredembodiment, cause the shuttle to flex, and as a result widen, such thatthe dimples are no longer in contact with the cut-out portion of thetissue penetrator. FIG. 9D illustrates the final step wherein the dimpleand finger spring are no longer touching the tissue penetrator at all,and the tissue penetrator may be retracted, leaving the shuttle 170free.

Thus, in various embodiments, the tissue penetrator 50 may be adapted tomate with one or more elements on the suture shuttle, whether it is adimple, or like protrusion, or finger springs, or the like, that canengage with a divot, depression, cut-out or ramp portion on the tissuepenetrator.

Shuttle 70, 170 and 270 may be made of any material suitable for use insurgical applications. In a preferred embodiment, the shuttle must havestrength, yet also have sufficient flexibility and resiliency to be ableto move on and off the tissue penetrator. Such movement requires theshuttle to flex during removal from and addition to the tissuepenetrator. Thus, a suitable spring characteristic may be achieved witha high stiffness material, such as steel, by designing the spring suchthat it has a high preload characteristic when installed relative to thetolerances. For example, one shuttle design illustrated herein mayinclude retention features that are lower spring stiffness & highpreload, which may help provide more consistent performance and decreasesensitivity to tolerances. Note that the intrinsic stiffness of thematerial (Young's modulus) and the spring constant of the shuttle may berelated, but may not be equivalent. In addition, these shuttle designsmay have significantly reduced tolerance sensitivity, wherein thetolerance is a small percentage of deflection, compared to other shuttledesigns. One suitable material may be stainless steel. For example, theshuttle may be composed of 0.004 in. (0.01 mm) thick 17-7 PH stainlesssteel, Condition CH-900.

Shuttle 70 may be made of material whose hardness is matched to thetissue penetrator 50. Tissue penetrators of a material that is too hardrelative to the shuttle may wear the shuttle out. In one example, thetissue penetrator is stainless steel, Rockwell 60C hardness. The shuttlethen may be precipitation hardened stainless steel, “17-4 PH”, which isalso known as stainless steel grade 630. The shape of the shuttle ismatched to the shape of the tissue penetrator, and the shuttle clipsonto a portion of the tissue penetrator, and can be slipped on and offrepeatedly.

The shuttle 70 may be made of a material having a hardness, stiffnessand elasticity sufficient so that it may partially elastically deflectto clamp onto the tissue penetrator 50. In particular, we have foundthat matching the hardness of the shuttle to the hardness of the tissuepenetrator may be particularly important for repeated use. For example,the shuttle may be made of Nitinol, beryllium copper, copper, stainlesssteel, and alloys of stainless steel (e.g., precipitation hardenedstainless steel such as 17-7 PH stainless steel), cermet (ceramic andmetal), various polymers, or other biocompatible materials. The materialchosen may be matched to the material of the tissue penetrator forvarious properties including, for example, hardness and the like. Theshuttles may be formed in any appropriate manner, including punching,progressive die, CNC, photolithography, molding, etc.

In the above examples, a pull-out force, or the force required to removethe shuttle 70 from the tissue penetrator 50, may be more than about 2pounds of force. Preferably, the force may be about 2 to about 5 pounds.The force may be from, for example, the pulling of a suture, or sutureclip or connector, attached through one of the bore holes 73 located onshuttle 70. This force should be from the direction of about the tip ofthe tissue penetrator.

In a preferred embodiment, illustrated in FIGS. 5A-B, the bore holes 73are located away from channel 71 and towards the base of the triangle,which may be in a fold in the shuttle, as shown in FIG. 5B. In the otherillustrated embodiments, FIGS. 6A-7 for example, the bore holes 173 areadjacent the channel. FIGS. 5A-B illustrate a position of bore holes 73which may reduce, or even eliminate, the bending forces on the sides ofshuttle 70, when suture, or the like, applies a force at bore holes 73.Typically, when bore holes 73 are located adjacent channel, as in FIG.6A, the bending force on the side of the shuttle may peel the shuttlefrom the tissue penetrator 50 at a force lower than the desired removalforce, due to the advantage of the force being applied to a corner ofthe shuttle 70. However, bore holes 73 located as shown in FIG. 5Blimits this bending force, or torque, and thus prevents removal ofshuttle 70 from tissue penetrator 50 at a premature time and at a forceless than is desired for removal of shuttle 70.

In another embodiment, the shuttle 70 may be in the shape of a spiraledwire, or the like, such as a “finger torture” type device, whereby asthe shuttle is pulled by the tissue penetrator 50, the shuttle maytighten around, thereby securing itself to the tissue penetrator. Thestronger the force of the pull, the tighter the spiraled wire secures tothe tissue penetrator. When the shuttle is to be transferred from thetissue penetrator, for example, to the shuttle retainer seat 25, theshuttle may be twisted, or the like, to “unlock” the shuttle from thetissue penetrator.

Other examples of shuttles 70, which may be able to clamp onto thetissue penetrator to secure itself, may be torsion springs, snap rings,a portion of wire, elastically deformable shapes, conically taperedshapes, and the like. Elastically deformable shapes may be any shapedesired, such that it can be deformed to wrap around at least a portionof the tissue penetrator. Useful shapes may include, but are not limitedto, cylinders, triangles, overlapping rings, and any partial portion ofa shape such as a semi-circle. Once the tissue penetrator is inposition, the shape of the tissue penetrator receiving area allows theelastically deformable shape to return to its original configurationwhile being securely attached to the tissue penetrator. Of course, thecut-out 51, or recess, or receiving area, on the tissue penetrator mayin a preferred embodiment be shaped such that it coincides with theshape of the shuttle. For example, if a conically tapered shuttle wereused, the tissue penetrator may include a conically tapered cut-out on aportion of the surface. The conically tapered shuttle may be deformable,and may deform upon being moved into the cut-out. Once completely withinthe cut-out, the conically tapered shuttle would return to its originalshape and secure itself within the cut-out. The cut-out may include, forexample, a lip, or the like, to assist in securing the shuttle, fully orpartially, within the cut-out.

In other embodiments, the shuttle may constitute the tip of the tissuepenetrator 50 itself, such that the tip may be releasably coupled on theend of the tissue penetrator. Thus, the tip of the tissue penetrator maybe passed between jaws of the suture passer device to pass the suture,which suture is attached to the tip, back and forth through the tissue.

Suture 90 may, in one embodiment, be attached directly to shuttle 70 atbore hole 73, or other like retention location. Of course, suture neednot be secured only by a bore hole. Instead, suture may be secured toshuttle by adhesive, a clamp, by being ties or engaged to a portion ofthe shuttle, or in any other suitable manner.

Additionally, suture 90 may be secured to shuttle 70 via an intermediarydevice, such as the various examples in FIGS. 10-15. One suchintermediary device may be a suture clip, or suture retainer, 80, 180,280 or 380. A suture clip allows for simple and efficient releasableconnection of a suture to a shuttle. A suture clip may be used forcontinuous suture passing, or alternatively for single passing of asuture.

In operation, suture clips 80, 180, 280, or 380, some examples of whichare illustrated in FIGS. 10-15, may be used as part of a system forsuturing tissue, particularly when used with a continuous suture passer10. For example, a suture 90 may be passed from the first jaw 20 to thesecond jaw 21 and/or back from the second jaw to the first jaw of asuture passer. This may be accomplished using an extendable tissuepenetrator 50 that is connected to the first jaw. The extendable tissuepenetrator can pierce the tissue, and can also engage a suture shuttle70, to which a suture is attached through the suture clip 80, 180, 280,380. The suture may then be pulled through the passage that the tissuepenetrator forms in the tissue. Extending the tissue penetrator forms apassage through the tissue, which may also pass the suture between thefirst and second jaws. For example, the tissue penetrator may include asuture shuttle engagement region which may be, for example, a cavitywithin the tissue penetrator, along the outside of the tissuepenetrator, or the like, to which the suture shuttle can be releasablyattached. The suture can be passed from the tissue penetrator in thefirst jaw to or from a suture shuttle retainer seat 25 connected to thesecond jaw. Thus, in a preferred embodiment, both the tissue penetratorand the suture shuttle retainer seat are configured to releasably securethe suture, which may be attached to a suture shuttle.

In some variations, the suture clip 80, 180, 280, 380 described hereinmay include an attachment linkage 85 to a suture shuttle 70, for examplea tether, leash, lead wire, or the like, which may be configured toconnect the suture clip to the shuttle. In some examples, the sutureclip includes a bias, for example, a spring, for securing a linkage 85within a snap-fit element. Alternatively, the suture clip may include acentral opening through which a linkage may be threaded. This linkagecan act as a spacer. In one embodiment, the linkage may be stifflyattached to the shuttle 70 such that it both spaces the shuttle from thesuture and also controls the position of the shuttle based on a forceexerted on the linkage. The linkage will also control the position ofthe suture as the shuttle is passed from one jaw to the other.

Similarly, the linkage 85 may be a stiff metallic wire, a portion ofsuture, a flexible polymeric strand, or the like. In the example of astiff metallic wire, the wire may be welded to the shuttle such that itmay project from the shuttle in a predictable manner.

In one embodiment, illustrated in FIG. 10, the shuttle 70 may beconnected to a suture clip 80 that may be a compressed loop, in whichthe compressed loop has an inner, generally “teardrop” shaped opening 86that is wider in one end than the other. The suture 90 may then bethreaded through the inner loop 86 such that it becomes wedged withinthe narrow portion of the teardrop shape. The suture may then be securedby any method known in the art such as by tying a knot or bringing theend outside of the body. The suture may also be secured solely by beingwedged within the teardrop shape, which may be sufficient to secure thesuture within the suture clip.

In an alternative embodiment, the suture clip may be a ring, which mayhave a circular outer shape and a circular inner opening. In thisexample, the suture would be passed through the circular inner openingand secured by any method known in the art such that the suture is noteasily separable from the suture clip.

In another embodiment, the suture clip 180, illustrated in FIGS. 11-12,may be a two-piece assembly that snaps together. The first piece 181 mayinclude a connector 186 for one of the suture 90 or linkage 85, whilethe second piece 182 may include a connector for the other of the suture90 or linkage 85. For example, a suture may be formed onto the secondpiece 182, or knotted onto the second piece, or the like. The first andsecond pieces are configured to be secured together. In some variations,the first and second pieces are configured to be releasably securedtogether. For example, the first and second piece may be snappedtogether, but may include a releasable securing element 183, such as abutton or the like, for separating them.

In FIGS. 11A-B, the suture clip 180 is shown with the first and secondpieces 181 and 182 forming the clip 180 when connected together. Theclip 180 may be configured so that it may readily pass through tissue.For example, the shape may be smooth, and may be tapered along the axisof its length. The surface may be lubricious or otherwise coated. Othershapes are possible.

This “snap-fit” example of a suture clip also may include a sutureretaining location on either of the pieces, or, alternatively, inbetween the two pieces. A lead wire, or other extension, may be securedwithin the eyelet 186, or alternatively on the tip of the second piece182, or also secure in between the two pieces.

The clip 180 may be separated into the first and second pieces byreleasing the securing element 183 between the two pieces. The first andsecond pieces of the assembly may also be referred to as “male” and“female” components. In the example shown in FIGS. 11A-B, the pieces maybe separated by applying pressure through the window region 184,releasing the securing element that holds the two pieces together.Snapping the first and second pieces together to from the assembly shownin FIG. 12 causes the securing element to engage and hold the first andsecond pieces together. The securing element may be disengaged byapplying pressure. For purposes of simplicity, in a preferredembodiment, the first and second pieces do not include either a sutureor an attachment linkage to the shuttle. It should be understood thatthese components may be included.

For example, the securing element 183, and the clip 180 as a whole, maybe made of a plastic polymeric material, a metal, or the like. Althoughthe latch is shown extending from the first piece 181, it mayalternatively extend from the second piece 182. More than one latch maybe used. Also, alternative variations of the latch may also be used.

The suture 90 and/or linkage 85 may be glued, heat-staked, or otherwiseattached permanently or semi-permanently to the second piece 182. Insome variations the suture may be knotted. For example, the suture orlinkage may be attached to the second piece 182 by first threading theend of the suture through the hollow second piece and then knotting thesuture; the larger-diameter knot will be retained by the second piecesince the suture knot cannot pass through the tapered orsmaller-diameter opening or passage in the second piece. In somevariations the second piece may be pre-threaded with a suture.

In use, a surgeon can easily snap the two pieces together, and theassembly may pass through the tissue with minimal drag. As mentioned,the assembly can be separated back into the first and second pieces byreleasing the latch, if necessary. The latch may be released manually,or by using a special tool configured to disengage the latch. Forexample, a disengaging tool may be used to clamp on the assembly in theproper orientation and to apply pressure to release the latch.

In a further embodiment, illustrated in FIG. 13A-B, the clip 280 may bea piece of tubing which has been laser cut to accommodate suture 90 andlinkage 85 connections. In a preferred embodiment, clip 280 may becrimped securely to suture at suture-attachment element 286. Linkage 85may be secured within the laser cut path 287. Additionally, suture 90may protrude into central region of clip 280 to interact with linkage85, which may also secure linkage 85 within laser cut path 287. Epoxy,or the link, may also be used to secure linkage in clip 280. The lasercut path 287 need not be formed by a laser, but may be machined in otherways known in the art. Alternative embodiments may exist where thelinkage 85 is connected to position 286 and suture is connected toposition 287. Additionally, linkage 85 may include a second portion of asuture.

In yet another embodiment, the suture clip 380 may include a flexibleplanar structure that is looped back on itself. This type of clip may beattached to an end of the suture, as illustrated in FIGS. 14-15. One endof the clip, which may include a suture-attachment element 386, may besecured to the end of the suture 90. The suture-attachment element maybe crimped to the suture and may be polymeric tubing, such ascyanoacrylate and polyester, for example. The opposite end of the clipmay be folded over itself to form a latch 387 within which a suture,wire or the like may be placed. The clip is secured to the suture at thesuture-attachment element, and is latched to a wire loop 85 which isattached to the shuttle. Of course, the clip may be reversed such thatthe clip engages the suture rather than the wire loop. Alternatively, ofcourse, the wire may be replaced by an additional suture or the like.

In yet another embodiment, illustrated in FIG. 16, the linkage 85 may bea wire loop. The wire may include nitinol. For example, FIG. 16 shows awire loop linkage 85 bonded in the middle to form a double-loopconstruction, having at least two loops, or in a preferred embodiment, a“Figure-8” shape. A double-loop or a Figure-8 shape may provideadditional safety in that if any portion of the wire loop linkage 85fails, the linkage remains fixed to at least one of the suture clip 80or the shuttle 70. Conversely, a wire loop linkage looped through boththe clip 80 and shuttle 70, as a mere loop of wire, may fall into thebody upon failing. In arthroscopic applications, this may create adangerous situation for the patient.

One embodiment of suture passer devices 10 may include a seating region25 into which the tissue penetrator engages. This region may be referredto as a seat, a tissue penetrating engagement region, or a shuttleretainer seat. For example, the suture passers described in the Ser. No.11/773,338 patent application (previously incorporated by reference) aswell as provisional patent application U.S. Ser. No. 60/985,543 (hereinincorporated by reference in its entirety) form a cavity or opening intowhich a tissue penetrator 50 can be inserted. In these devices, in apreferred embodiment, a suture shuttle 70 is passed between the tissuepenetrator 50 and the seat 25, although shuttleless variations (asdescribed below) may also include a seat region for engaging the tissuepenetrator and suture 90.

FIGS. 17-19 illustrate various embodiments of the shuttle retainer seat25, 125. The shuttle retainer seat may be positioned with respect to thelower jaw 21, and in a preferred embodiment, within the lower jaw 21 asshown. Hole and pin 126, 26, respectively, may be for the attachment ofa stiff member 32′ which may rotate the shuttle retainer seat tosubstantially match the motion, or angle of approach, of the tissuepenetrator 50, such that the shuttle retainer seat is moved tosubstantially match the angle of penetration of the tissue penetratorinto the shuttle retainer seat. The amount of motion required may bedependent upon the distance the jaws 20 and 21 are spread apart. Thus,no matter the distance between jaws 20 and 21, the shuttle retainer seatmay move complimentary to any direction from which the tissue penetrator50 is extending from jaw 20 towards jaw 21 and shuttle retainer seat 25,125. Opening 28, 128 in the suture retaining seat provides a throughwayfor a set screw or a retaining pin, for example, which may secure theshuttle 70 within the suture retaining seat.

FIG. 19 illustrates, in one embodiment, an example of the interaction ofthe shuttle 70 and the shuttle retaining seat 125. The shuttle is lodgedwithin the central cavity of shuttle retaining seat. The tissuepenetrator may then enter through the central bore of both shuttle andshuttle retainer seat to retrieve the shuttle.

In another embodiment, illustrated in FIGS. 17A-B, the shuttle retainerseat 25 may include flexible seat portions 27, which may contact twosides of shuttle 70, while providing additional clearance for shuttleand tissue penetrator during insertion and removal. The flexible seatportions 27 may provide dynamic clearance for expanding shuttle sides,during release from tissue penetrator 50, thus accommodating shuttleflexure. Further, the device 10 may be more reliable because theflexible seat portions may lessen any effects of high forces during theseating process.

When these devices are used with some tissue, especially softer, tissuemay prolapse into the seat as the tissue is secured between the jaws.This prolapsed tissue may prevent complete penetration by the tissuepenetrator, and may also interfere with the operation of the suturepasser. In order to prevent the tissue from entering the inner portionof the seat, the shuttle retainer seat 25 may include prominent sidewalls against which the tissue may be pressed by the collapsing of jaws20 and 21 around the tissue. The side walls may stretch the tissue, orassist is pulling it taught, to prevent the tissue from prolapsing intothe seat where the shuttle is retained. Maintaining pressure on thetissue during puncturing with the tissue penetrator may also form acleaner cut by the tissue penetrator. These anti-prolapse features mayalso be incorporated into the non-moving lower jaw component 21 or onthe upper jaw 20, rather than on the shuttle retainer seat 25, withspreading features disposed on each side of the shuttle retainer seat.

FIGS. 20A-B illustrate one embodiment of the mechanics within lower jaw21 concerning the shuttle retainer seat 25 and retaining pin 30. As thefigures suggest, in a preferred embodiment, shuttle retainer seat 25 maypivot within lower jaw 21, and retaining pin 30 may remain in contactthroughout the seat's range of motion.

Retaining pin 30 may be moveable in the forward and rearward directionalong its longitudinal axis, and may further be spring loaded to providea force in at least one of the distal or proximal directions, asrequired.

Shuttle retainer seat 25 may, in a preferred embodiment, include a camsurface 29 on which retaining pin 30 may at least partially interact.The cam surface 29 may limit retainer pin 30 movement, or depth, intothe central bore of seat 25, thereby eliminating interference ofretaining pin with tissue penetrator 50. Additionally, cam surface 29may provide spring loaded rotation of shuttle retainer seat to theposition needed to interact with the tissue penetrator. For example, theretaining pin 30 may be adjusted dependent upon the distance the jaws20, 21 are apart. The adjustment of retaining pin applies a force on thecam surface 29 of seat 25, thereby rotating the seat to the desirableposition. In a preferred embodiment, the cam surface 29 may maintain aprecise retaining pin protrusion distance into the seat for any seatrotation angle. This may prevent the tissue penetrator from adverselyinteracting with the pin, aside from any proximal deflection of theretainer pin caused by the tissue penetrator contacting the pin radius31, as the tissue penetrator enters the seat. Further, a second portionof cam surface 29 (labeled as seat radius 29′) may interact with tissuepenetrator 50 as tissue penetrator 50 extends into shuttle retainer seat25. This interaction may provide further alignment of shuttle retainerseat 25 and tissue penetrator 50 for tissue penetrator 50—shuttle 70interaction.

Additionally, once tissue penetrator 50 exits from shuttle retainer seat25, seat may return to its original position. This may occur once tissuepenetrator terminates contact with seat radius 29′, allowing seat toreturn to its starting position. Upon withdrawal of tissue penetrator,retainer pin 30 returns to its distal position. Retainer pin may thenalso interact with cam surface 29 to return the seat to its originalposition.

In a further embodiment, shown in FIG. 21, retainer pin 30 may beconsidered passive, wherein the spring, which pushes the pin distally,is not displaced dependent upon the other factors, such as the distancebetween jaws 20 and 21. As such, passive retainer pin 30 is held in adistal position in lower jaw 21, which also therefore holds shuttleretainer seat 25 in a distal position as well. In this embodiment,shuttle retainer seat 25 includes a seat radius 29′, which is the radiusof a portion of cam surface 29, and retainer pin includes a pin radius31. Seat radius and pin radius may interact with tissue penetrator 50upon extension of tissue penetrator from upper jaw 20 towards lower jaw21. As tissue penetrator 50 comes into contact with shuttle retainerseat 25, it may contact both seat radius 29′ and pin radius 31, therebyrotating seat 25 to the desired position (which is dependent upon tissuepenetrator angle of entry, which is dependent upon the distance betweenthe jaws), for tissue penetrator entry and collection of shuttle 70.Similarly, the entry of tissue penetrator, upon contact pin radius 31,pushes against pin 30 and pushes pin, against its spring force, in theproximal direction. In this embodiment, the lower jaw 21 mechanics arepassive, and are adjusted to proper angles and positions by the tissuepenetrator contacting the pin and seat radii to create the adjustmentnecessary for proper tissue penetrator—seat alignment for precisecollection of shuttle 70.

In yet another embodiment, FIG. 22 illustrates a shuttle retainer seat25 which may include a further degree-of-freedom aside from theaforementioned rotational degree-of-freedom. In one example, seat 25 mayhave a translational movement in the distal-proximal direction throughat least a portion of the longitudinal length of lower jaw 21. Arrow Aillustrates the translational motion in the proximal direction, from theinitial distal position of seat 25. This added degree-of-freedom mayprovide further optimal alignment of seat with respect to tissuepenetrator 50. Further, it may provide a more compliant landing area fortissue penetrator, accommodating any tissue penetrator targeting errorswhich may occur. As such, seat 25 is not constrained to its exactmounting location on lower jaw 21.

FIG. 23 illustrates a first embodiment of the initial set-up of suturepasser device 10, prior to use. In this example, shuttle 70 may beinitially positioned within shuttle retainer seat 25. Shuttle retainerseat may include a stop within its core to regulate the depth to whichshuttle 70 may be positioned. Also, since inner core of seat 25 may betapered, the stop would prevent jamming of the shuttle 70 within thetaper.

Spring 32 of retainer pin 30 may be used to preload shuttle 70. Asshuttle is inserted into seat 25, retainer pin 30 moves proximally asshuttle engages pin radius 31. Once the shuttle is in place, retainerpin 30, through a force from spring 32, returns to its distal position.In this position, retainer pin 30 may pass through a U-shaped notch 76on shuttle 70 (see FIG. 24), thereby securing shuttle within seat 25.Upon retainer pin 30 returning to its distal position, spring 32illustrates its function in lower jaw 21. For example, in a preferredembodiment, the spring's 32 distal force has several functionsincluding, but not limited to: pushing retainer pin 30 distally tocapture shuttle, pushing the seat distally into a receptive position fortissue penetrator insertion, providing rotational torque to rotate seatinto an optimal angle for tissue penetrator insertion based on theinteraction of cam surface 29 and retainer pin 30.

FIGS. 24 and 25 further illustrate the interaction of shuttle 70 andretaining pin 30 in this embodiment. The U-shaped notch 76 is similar tothe oval slot, or opening, 174 and 274 of other shuttle embodiments (seeFIGS. 6B and 7). However, unlike the oval slot, the U-shaped notch, of apreferred embodiment, provides easier access into the area by the tissuepenetrator, as well as allowing tissue penetrator to rotate seat 25without portions of shuttle 70 interfering with process.

Similarly, in a preferred embodiment, when shuttle 70 is located ontissue penetrator 50, and tissue penetrator 50 extends from upper jaw 20towards lower jaw 21 and seat 25, the tip of tissue penetrator acts onseat and retainer pin 30 in much the same way as when shuttle is locatedwithin seat 25. Therefore, as tissue penetrator 50 moves into thecentral bore of seat 25, the tip of tissue penetrator 50 engages theseat radius and pin radius 29′ and 31 which may properly align seat 25with tissue penetrator 50, as well as push retainer pin 30 proximallyand away from seat 25. Once tissue penetrator 50 is extended fully intoseat 25, shuttle 70 may be within seat as well, and may further be inthe proper position within seat for securing itself therein. Thus,retainer pin 30 may move distally once the U-shaped notch 76 passesthrough the longitudinal path of retainer pin 30. As retainer pin 30moves distally, it may pass at least partially through U-shaped notch,thereby securing shuttle 70 within seat 25. The tissue penetrator 50 maythen be retracted, leaving shuttle 70 within seat 25. Tissue penetrator50 may then extend once again into seat 25 to collect shuttle 70, inwhich the reverse occurs and tissue penetrator 50 pushes retainer pin 30proximally and shuttle 70 may then be collected.

In one embodiment, shuttle retainer seat 25 may be press-fit into lowerjaw 21. In a first example, as shown in FIG. 26, lower jaw 21 mayinclude flexible side members 22 a and b, which flex as shuttle retainerseat 25 is inserted into place. Once in place, flexible side members 22a and b return to their original position, securing seat in betweenthem. As such, flexible side members may include a groove on the innersurfaces, or the like, so that the inner width in between the flexibleside members is wider than on the edges. In a second example, as in FIG.27, the side members of lower jaw 21 may include a tapered lead-inelement 23 such that seat may be wedged within the taper. Other similarfeatures may also be used to secure seat within lower jaw member 21.

In an alternative embodiment, in FIG. 28, shuttle retainer seat 25 mayinstead be controlled by a stiff member 32′. Stiff member 32′ may rotateshuttle retainer seat, as the upper and lower jaws 20 and 21 moverelative to one another, to maintain the proper angle with the tissuepenetrator. The stiff member 32′ is controlled via mechanisms in theactuator 15 of device 10 to ensure proper alignment.

FIGS. 29A-29K illustrate cross-sectional views of a preferred embodimentof the interaction of shuttle 70, shuttle retainer seat 25, retainer pin30 and tissue penetrator 50 at lower jaw 21. Many of the operationsdiscussed above would be used in this illustrated series of actions.

In FIG. 29A, shuttle 70 may be secured within shuttle retainer seat 25by retainer pin 30 in lower jaw 21. Tissue penetrator 50 is shown to beabove lower jaw 21.

In FIG. 29B, tissue penetrator 50 may pass through shuttle retainer seat25, where shuttle 70 may be located, and may push retainer pin 30proximally. As discussed earlier, the shuttle retainer seat 25 may bemovable to accommodate the entry angle of tissue penetrator 50.

In FIG. 29C, tissue penetrator 50 may extend fully into shuttle retainerseat 25, engaging the shuttle 70. Retainer pin 30 may move distallyagain, back to its original position, and into groove on the backportion of the tissue penetrator (as well as through the U-shapedportion of the shuttle 70, not shown), due to the spring force pushingthe retainer pin distally.

FIG. 29D illustrates the retainer pin 30 being manually retractedproximally, through use of the actuator 15 (discussed below), todisengage the retainer pin from the shuttle 70.

In FIG. 29E, the tissue penetrator 50, with shuttle 70 engaged, may beretracted out of the lower jaw 21 and back towards upper jaw 20. Theshuttle 70 may be removed from the shuttle retainer seat 25 when theretainer pin 30 is retracted proximally, as shown. FIGS. 29A-29Eillustrates one example of the tissue penetrator 50 engaging shuttle 70,located in the shuttle retainer seat 25, and retracting shuttle 70 up toupper jaw 20.

In FIG. 29F, the tissue penetrator 50, with engaged shuttle 70, may beretracted back to upper jaw 20, and actuator 15 is released such thatretainer pin 30 may move back to its original, distally located,position. This may be considered to be one pass of the shuttle 70, whichmay have suture and/or suture clip attached.

In FIGS. 29G-29K, an example of a second pass is illustrated where theshuttle is passed from the tissue penetrator 50 to the shuttle retainerseat. In FIG. 29G, the tissue penetrator is extended from upper jaw 20towards lower jaw 21. Shuttle 70 may be engaged on tissue penetrator 50.Retainer pin 30 may be in a distal position.

In FIG. 29H, the tissue penetrator 50 and engaged shuttle 70 enter intoshuttle retainer seat 25. Retainer pin 30 may be pushed proximally bythe tissue penetrator 50 and/or engaged shuttle 70.

In FIG. 29I, the tissue penetrator 50 may be extended completely suchthat retainer pin 30 may return to a distal position, thereby passingthrough, for example, the U-shaped opening (not shown) on shuttle 70 andthe groove within tissue penetrator 50. Shuttle 70 may now be securedwithin shuttle retainer seat 25, and may even still be engaged on tissuepenetrator 50.

FIG. 29J illustrates tissue penetrator 50 retracting from shuttleretainer seat 25 and lower jaw 21. Retainer pin 30, though pushedproximally, once again, by the movement of tissue penetrator 50, thespring (not shown) within retainer pin 30 may still be sufficient tomaintain the retainer pin 30 in a position as distal as possible suchthat shuttle 70 may still be retained within shuttle retainer seat 25 byretainer pin 30. The force on the shuttle 70, applied by retainer pin30, and against the movement of tissue penetrator 50, may cause aretaining structure, such as the dimple/divot structures discussedabove, to disengage such that tissue penetrator and shuttle disengagefrom each other. Shuttle 70 is thus retained within shuttle retainerseat 25.

In FIG. 29K, the tissue penetrator 50 may retract completely away fromshuttle retainer seat 25, and retainer pin 30 may then move distally toreturn to its original position. Shuttle 70 is therefore secured withinshuttle retainer seat 25 by retaining pin 30. Tissue penetrator 50 mayretract completely back to upper jaw 20.

Thus FIGS. 29A-29K illustrate one embodiment of the interaction of thetissue penetrator 50, shuttle 70, shuttle retainer seat 25 and retainerpin 30. This interaction may include the various mechanisms, structuresand operations discussed throughout.

The jaws 20 and 21 can be moved totally independently of the tissuepenetrator 50. The jaws may be used to grasp and manipulate tissue priorto suture passage. As described below, since the tissue penetrator andjaws operate independently of one another, the jaws may be used asgraspers without having to expose the tissue penetrator.

In one embodiment, the upper and lower jaws 20 and 21 may movekinematically in that they may remain substantially parallel to oneanother when the lower jaw is brought away from the upper jaw. Forexample, in FIGS. 30A-B, illustrating a preferred embodiment, lower jawis pivotally attached to pivot arm 19. Pivot arm 19 is then attached tosliding element 18 which may slide along the outer surface of shaft 17.In this example, when lower jaw is moved away from upper jaw, slidingelement 18 moves distally along shaft 17 such that lower jaw may remainparallel to upper jaw. This sliding movement compensates for thetracking error of the pivot arm, also known as a 4-bar linkage, suchthat the lower jaw may track the arc traversed by the tissue penetrator50. Additionally, this movement of the sliding element 18 allows thelower jaw 21 to remain substantially directly opposite the upper jaw 20throughout the range of motion of the lower jaw. As a further example,if the lower jaw were not attached to the sliding element, the lowerjaw, as it moves away from the upper jaw, would also move proximally,relative to the upper jaw, and thus be out of alignment with upper jaw.

Aside from the sliding pivot arm example above, other mechanisms suchas, for example, gear drives, linkages, cable drives, and the like, maybe used to ensure proper alignment of top and bottom jaws 20 and 21during jaw actuation.

The upper jaw 20 may be fixed in place as to shaft 17. The fixed upperjaw may provide many advantages to a moveable upper jaw, such asproviding a reference point for the surgeon, allowing for independentadjustability of the jaws and tissue penetrator engagement position, andthe like.

The parallel relationship of the upper and lower jaws 20 and 21 of thisembodiment allow for easier manipulation of tissue, while alsopreventing the jaws from overly impinging any portion of the tissue. Forexample, if the jaws opened as a typical V-shaped pattern, then theproximal tissue, deeper into the V shape, would have excess force on itthan the distal portion of the tissue, within the jaws. The parallelrelationship ensures that the force of the jaws is spread equallythroughout the tissue in between the jaws.

In an alternative embodiment, the upper jaw 20 may slide distally andproximally, while the attachment point of pivot arm 17 remainsstationary. Thus, as the lower jaw moves away from the upper jaw, theupper jaw moves proximally to maintain alignment with the lower jaw.FIGS. 31 and 32A-C illustrate this embodiment.

Also illustrated in FIG. 31 are the various entry angles of the tissuepenetrator when the upper and lower jaws are at various distances fromone another. For example, the tissue penetrator will meet the shuttleretainer seat, located in the lower jaw, no matter the separationbetween the upper and lower jaws. Thus, the jaws may be clamped totissue of any depth, and the tissue penetrator will pass through thetissue and hit the lower jaw directly at the shuttle retainer seat.

For example, in FIG. 31, upper and lower jaws 20 and 21 may have aninitial position (a). The expansion of the jaws, illustrated bypositions (a)-(c), may occur by the lower jaw 21 pivoting away fromupper 20, while upper jaw 20 slides proximally to maintain a functionalrelationship between the jaws as the lower jaw 21 pivots. FIG. 31 alsoillustrates the extension of tissue penetrator 50 from the upper jaw 20to the lower 21, in positions (a) and (b) to (d) and (e). Positions(d)-(h) of FIG. 31 illustrate a further method wherein the simultaneousexpansion of jaws 20 and 21 and extension of tissue penetrator 50 mayoccur. Additionally, FIG. 31 illustrates in positions (c) to (h), theextension of the tissue penetrator 50 when jaws 20 and 21 are expanded.As such, FIG. 31 illustrates one embodiment of the device 10 in whichthe lower jaw 21 may track the arcuate path of tissue penetrator 50,such that tissue penetrator 50 may engage the lower jaw 21 at thesubstantially same position regardless of the position of the lower jaw21. FIGS. 32A-C further illustrate the arcuate path the lower jaw 21 maytravel.

The size of the suture passer device 10 may be any size useful inperforming surgery on the body. For example, for many arthroscopic jointsurgeries, the upper and lower jaws may be around 16 mm in length,though a length of up to about 25 mm is obtainable. This may besignificantly scaled down for a device for use in, for example, wristsurgery. Alternatively, a larger device, with larger jaws, may be usefulfor hip or torso surgery.

In further examples, the suture passer device may, for example, be ableto pass suture through any tissue up to about 10 mm, though a scaled upversion of the device may allow for greater amounts of tissue. Moreover,in most embodiments, the device may pass through a standard 8 mmcannula.

Actuator Mechanism Examples

The suture passer devices 10 described above may include, for example,three types of controlled motion: (1) the open/close movement of thejaws, whereby at least one jaw moves relative to the other; (2) theextension/retraction of the tissue penetrator; and, optionally, (3) theretention/release of the shuttle retaining pin 30 from the seat 25 onthe second jaw. Although there are numerous ways in which these motionsmay be accomplished, including those described in the 11/773,338application, and various provisional applications already incorporatedby reference herein, described below are mechanical assemblies (alsoreferred to as “layers”) that may be used to precisely control thesethree types of motions of the suture passer. These layers are referredto as the jaw motion control layer or the conjugate motion control layer(controlling the relative motion of the jaws), the tissue penetratorcontrol layer (controlling the motion of the tissue penetrator), and theretaining pin control layer (controlling the motion of the shuttleretainer seat and/or retaining pin).

Although these layers are described here in the context of a suturepasser, it should be clear that the techniques and principles describedherein may be applicable to other devices, particularly those havingmovable jaws and/or other movable features. For example, the conjugatemotion control layer may be used to control a forceps, clamp, or otherdevice. Thus, the invention should not be limited to the figuresdescribed herein, or the specific embodiments.

1. Jaw Motion Control Layer

The jaws 20 and 21 move to open and close in parallel. This means thatthe inner surfaces of the jaws (e.g., the downward-facing surface of theupper jaw and the upward-facing surface of the lower jaw) open and closeso that they are substantially parallel. The jaws also move so that thetissue penetrator 50 extending from the first jaw contacts roughly thesame position on the second jaw, for example, the shuttle retainer seat25, when the tissue penetrator is extended, regardless of how open orhow closed the jaws are relative to each other.

It should also be pointed out that the conjugate motion of the jaws mayalso be semi-parallel. For example, in one variation, the device mayhave a non-parallel 4-bar linkage by changing the length of the links,resulting in a semi-parallel motion. This may be beneficial for somesurgical procedures.

In a first embodiment, illustrated in FIG. 33, the lower jaw controlmechanism may control both the lower jaw 21 opening and closing, as wellas the movement of sliding element 18. While two separate mechanisms mayperform the same function overall, the present invention is capable ofusing a single lower jaw control mechanism to perform both movementswith a single mechanism. The coordination of these two motions allowlower jaw 21 to accurately track the arcuate path of the tissuepenetrator 50 extending from upper jaw 20, which in this example, isstationary.

In this example, the actuator 15 encloses a jaw trigger 304 which mayserve as the manual interface for the user. The trigger 304 may bepushed or pulled, along arc B, depending on the desire of the surgeon toopen or close the lower jaw 21. The mechanism may include two linearbushings 302, which drive the respective control rods and links 301 toactivate the sliding element 18 and the lower jaw 21 and pivot arm 19.Each bushing is responsible for the movement of one of the lower jaw 21and pivot arm 19 or the sliding element 18. The pivot point 303 of thetrigger 304 is at different distances from the two linear bushings 302.Thus, the bushings drive the control rods and links 301 at relativelydifferent rates and distances. Thus, the actual traveling distances ofthe lower jaw 21 and sliding element 18 may be different. Thesedistances may be determined and set so that the lower jaw 21 travelapproximates the same arcuate path as tissue penetrator 50.

This mechanism may be rigid in order to minimize errors as to clampingpressure and location during use.

The jaws 20 and 21 may also be locked in any position by a lock, such asa valve, latch, pin or the like. This is important because it allowsleverage for penetrating the tissue, such that one may bear down on thetrigger for the tissue penetrator without worrying about damaging thetissue.

In a preferred embodiment, illustrated in FIGS. 34A-C, a lockingmechanism may be a ratchet mechanism 309. Ratchet 309 may be positionedon trigger 304, and may further have an interface portion 306 placed onfinger spaces of trigger 304, which allows for convenient use by a user.A pawl 305 includes the ratchet 309, interface portion 306 and a pivot307. A spring 308 may be included to provide a set position of pawl 305.In the illustrated example, the spring 308 provides a set position ofthe ratchet being engaged, however, any configuration may be used.

In operation, this exemplary lock may allow the user to lock the jaws 20and 21 at a set distance from one another. The user may pull trigger 304backward, using a first finger at location 304 a, until the jaws are atthe desired clamped position around tissue. While the trigger is pulled,the ratchet, in the engaged set position, allows the trigger to movebackward, but will not allow the trigger to move forward. Spring 308maintains a force on pawl 305 to ensure ratchet remains engaged. Thus,the trigger moves from a first position, FIG. 34A, to a second position,FIG. 34B, and is secured by ratchet 309.

The user may then proceed to do other procedures, such as extending thetissue penetrator or the like. This mechanism may assist the user inmaintaining jaw position during tissue penetrator deployment, as well asmaintaining constant pressure on the tissue to increase tissuepenetrator targeting accuracy. Of course, engaging the ratchet andlocking the jaws in place may solely be used as a grasper, withoutdeploying the tissue penetrator. Once the user has completed the task,and is ready to disengage the jaws 20 and 21, the user may press thetrigger at the second position 304 b, using a second finger, therebyalso pressing on interface portion 306 which may disengage the ratchet309. The interface portion 306 is pressed hard enough to disengage theratchet, but light enough to allow the trigger 304 to move forward andopen the jaws, as illustrated in FIG. 34C.

In a preferred embodiment, the pawl 305 is attached to trigger 304 atpivot 307, and the ratchet portion 309 may be secured to the actuatorshell (15, generally) such that is in a fixed position.

2. Tissue Penetrator Control Layer

As illustrated in FIGS. 35A-B, one embodiment of the components thatmake up the tissue penetrator control layer may include at least thetissue penetrator 50, coaxial tissue penetrator push/pull rod (notshown, but connects drive block 356 with tissue penetrator 50), and thesubassembly linking the push/pull rod to the tissue penetrator controltrigger 355. The tissue penetrator control trigger 355 may act directlyon the tissue penetrator.

In a preferred embodiment, the trigger 355 is a push/pull system,meaning the trigger can be either pushed or pulled, along path LC, todirect the tissue penetrator in or out of upper jaw 20. The trigger 355may be spring loaded, such that, for example, the trigger is biased suchthat the tissue penetrator 50 is retracted, within the upper jaw 20.

The trigger 355 may further include a first pivot 359, wherein therotational motion of the trigger 355 is turned into linear motion of thedrive block 356, along path D, through the connection at a pin and slotinterface 358. The drive block is limited to linear motion by the use ofat least one linear bearing 357. The linear motion of drive block 356applies a force directly on the tissue penetrator 50 to push and pullthe tissue penetrator as desired by the manual motions of the surgeon.

As illustrated in FIGS. 38A-C, the tissue penetrator control may furtherinclude limit stop capabilities to prevent tissue penetrator fromadvancing too far into shuttle retainer seat 25. Further, the limit stop349 is correlated to the amount the jaws 20 and 21 are open, such thatfor example, the limit stop 349 allows a wide range of motion when thejaws are spread far apart, and a narrower range of motion when the jawsare closer together.

The limit stop 349 may be directly correlated such that the stop occursprecisely when the tissue penetrator 50 is in the correct locationwithin the seat 25. Furthermore, this limit stop 349 may be related tolimit stop 335 in retainer pin 30 actuator (FIG. 37A), such thatretainer pin 30 only actuates when tissue penetrator is within seat 25in a location wherein it may collect shuttle 70.

Limit stop 349 may be located on drive block 356, but interacts with thejaw control layer, discussed above, such that it may provide a properlimit stop customized to the position of lower jaw 21 in relation toupper jaw 20.

Limit stop 349 operates to limit the motion of drive block 356 to acertain distance required. This certain distance is determined by thedistance the jaws are spread apart. For example, in FIGS. 38A-B, thetrigger 304 is positioned such that the jaws are fully open. Thus, thetissue penetrator, if activated at the point as shown in FIG. 38A, thetissue penetrator would have to travel a long distance, to the positionshown in FIG. 38B, to span the gap between the upper and lower jaws.Thus, as can be seen by the change in distance between the two referencelines a′ and b′, from FIG. 38A to FIG. 38B, the drive block 356 travelsa large distance, denoting a large distance the tissue penetrator hasmoved. Conversely, in FIG. 38C, the trigger is positioned such that thejaws are in a closed position. Comparing the reference lines a′ and b′in FIGS. 38A and 38C illustrate that the drive block would travel a muchshorter distance in FIG. 38C, than in FIG. 38A to FIG. 38B. The distancethe drive block can travel is in direct relation to the change inposition of trigger 304 altering the distance between it and the stoplimit 349.

3. Retaining Pin Actuator Control Layer

In one embodiment, the retaining pin actuator control may be locatedwithin and incorporated into the tissue penetrator control layer,previously discussed. Such a relationship between the tissue penetratorand actuator pin may be beneficial in achieving accurate communicationbetween both elements in the jaws 20 and 21. FIGS. 36A-B illustrate twopivot points 358 and 359 within the tissue penetrator control layer,which may work consecutively. Pivot point 358 is the aforementioned pinand slot interface which may interface the trigger 355 with the retainercontrol layer. Pivot point 359 may control tissue penetrator 50.

In operation of this first embodiment, the trigger 355 is pulled, forexample, and may pivot around first pivot 359 to extend tissuepenetrator 50. Once tissue penetrator is fully extended, the triggerreaches a stop, at the position illustrated in FIGS. 35B and 36A. If theuser continues pulling on the trigger, the trigger may then pivot aroundthe pin and slot interface 358, which may pull the retaining pin 30proximally, and away from shuttle retainer seat 25 and shuttle 70.

As discussed above, in a preferred embodiment, the retainer pin 30 maybe passive, meaning that the tissue penetrator 50 may be inserted intothe lower jaw 21 without having to first retract the retainer pin 30.This is possible because of the pin radius 31 and spring 32.

Retainer pin control layer may further include, in a preferredembodiment, a capstan 340, FIGS. 37A-C, which interfaces the retainerpin 30 with trigger 355. Capstan 340 may include a connection withretaining pin 30, such as a wire 333, a spring 336, and a resetinterface 334 and stop pin 335. The capstan may be pulled proximally bytrigger 355, in the direction shown as line E in FIG. 37B. Capstan movesproximally, as reset interface 334 moves past stop pin 335. A projection337 on reset interface 334 may move from one side to the other of stoppin. At this point, capstan may be secured in place, thereby securingthe retainer pin 30 in place at a position proximal to its normal,passive position adjacent shuttle retainer seat 25. Stop pin 335 may bereleased when driver block 356 returns to its rest location. Oncetrigger 355 is released, driver block 356 may return to its startingposition, which may release capstan 340 by interfacing with the resetinterface 334, to disengage stop pin 335, which then may return retainerpin 30 to its starting position.

Wire 333, as illustrated in FIGS. 37A-C, may connect capstan 340 withretaining pin 30. Wire 333 may run through two pulleys, 333′ and 333″.At least one of the pulleys, as shown in FIGS. 39A-B, shown as pulley333′, may be positioned within actuator 15 in a stationary position suchthat does not move relative to the device 10. Pulley 333″, however, maybe positioned such that it moves with the jaw actuation mechanism layer.For example, in FIG. 39A, the jaws 20 and 21 are open relative to oneanother, and in FIG. 39B the jaws are closed. When the lower jaw movesto a closed position, it comes in line with shaft 17, in effect,shortening the distance between retainer pin 30, in the lower jaw 21,and pulley 333″. As a result, the wire 333 would be too long. However,if pulley 333″ moves backward, as shown in FIG. 39B, it will maintainthe same distance between retainer pin 30 and pulley 333″, therebypreventing the wire 333 from losing tension as lower jaw 21 closes.

The retainer actuator control layer may further include a bi-modalstroke limiter, or the like. This limiter ensures that the retaining pin30 is only actuated when shuttle 70 is properly positioned withinshuttle retainer seat 25. FIGS. 40-43 illustrate various configurationsof the bi-modal stroke limiter.

For example, in a typical tissue penetrator operation cycle, the tissuepenetrator trigger 355 may pull capstan 340 in the proximal direction,thus pulling retainer pin 30 using wire 333. Spring 336, extending fromcapstan 340, links with trigger 355. Trigger 355 may include slide block341, which houses, on its underside, a wire-form pin 342. The operationcycle has, for example, four cycles in which wire-form pin has fourpositions: 1) stable resting position, 2) short travel position, 3)stable resting position, and 4) long travel position. Position (1) isillustrated in FIGS. 40A-B and 43A. The spring 336 is lax, and trigger355 is not engaged. Wire-form pin 342 is also at a resting position,against the body of slide block 341. Position (3) is identical toPosition (1), except the actual position of wire-form pin 342 may bedifferent, as in FIG. 43C, but still designates a rest position.Position (2), illustrated in FIGS. 41A-B and 43B, is for a short travel,in which only the tissue penetrator 50 is activated. The capstan remainsin position, and retainer pin 30 remains in position adjacent shuttleretainer seat. In Position (4), as in FIGS. 42A-B and 43D, long traveltakes place in which spring 336, capstan, wire 333 and retainer pin areactivated, thereby moving retainer pin proximally.

The wire-form pin 342 is located within a labyrinth 343 on the undersideof side block 341. The various cycles are denoted by the variouspositions of the wire-form pin within the labyrinth.

Undesirable movement within the linkage between the capstan 340 andtrigger 355 may be absorbed by spring 336. Once spring is extended,over-travel of mechanism may be handled by the stiff extension propertyof the spring 336. Spring 336, therefore, operates to absorb shocks andunwanted movements within the mechanism, which may ensure smooth andpredictable operation.

In some other embodiments of the device, at least a portion of thedevice, for example, a control system, may be electronic. For example,hardware, firmware, and/or software may be used to control the motion ofthe jaws, shuttle retainer/seat, shuttle, and/or tissue penetrator.

For example, a RISC chip, e.g., a PIC (Microchip Corp.) processor maycoordinate and control the upper jaw position relative to the lower jaw(conjugate motion), in the embodiment where the upper jaw is movable, byusing a potentiometer or similar position encoder on the trigger. Alinear or rotational electromagnetic actuator may be used to positionthe upper jaw. Further, it could also control an electromagnetic brake,if needed, to lock the position of the upper jaw.

Additionally or alternatively, a processor could also handle all of theretainer actuator functions. It could receive input or calculate whetherthe shuttle is going up or down, and it could control the retainer cabletension by way of another electromagnetic actuator, such as a simplesolenoid or length of shape memory alloy actuator wire.

Such devices could trade many machined and molded parts, as previouslydescribed, for off the shelf actuators commonly used in high volumeconsumer devices. This could drastically reduce total cost of goods andallow more precise timing of retainer actuator events.

In a further example, the tissue penetrator and/or shuttle retainer seatrelative position could also be monitored with a sensor and thus closethe loop, electronically ensuring that the tissue penetrator alwaysfinds its target even under severe usage conditions. This kind of closedloop control may be regulated with a microprocessor.

Electronics, or firmware, is very reliable and immune to tolerances. Asthe device is scaled, for example, shrunk for laparoscopic applications,there may be additional ways to offset the added expense and adapt tothe even more severe precision requirements. An embedded/electromagneticsolution is one possibility.

In some embodiments, the suture passer device 110 may pass a suture backand forth through a tissue or tissues without the use of a sutureshuttle.

In general, the shuttleless suture passers may have two jaws that mayopen and close in parallel and pass a suture between them. Atissue-penetrating member may releasably grasp a suture and hand it offto a suture retainer that can also releasably grasp the suture. FIG. 44illustrates one embodiment of a shuttleless suture passer that includesan upper jaw with a suture grasper and a lower jaw with another suturegrasper.

In FIG. 44, the suture 90 is initially held in the upper jaw of thesuture passer. The lower jaw and the upper jaw may be opened and closedin parallel to any degree, so that tissue can be secured between them.The tissue penetrator can be extended from within the upper jaw, throughany tissue between the jaws, and into the engagement region on the lowerjaw. Once in the engagement region, the upper suture grasper (notvisible) releases the suture into the lower suture grasper in the lowerjaw. After retracting the tissue penetrator, at least part way, out ofthe engagement region, the device may be repositioned so that the suturecan be passed from the lower jaw to the upper jaw. The tissue penetratorincluding a suture grasper may be extended into the engagement regionagain, and the suture grasper in the lower jaw can be toggled by, forexample, engaging the tissue penetrator, to release the suture into thesuture grasper on the tissue penetrator. Retracting the tissuepenetrator pulls the suture back through the tissue towards the upperjaw.

As mentioned, any appropriate suture grasper may be used. For example,mechanical suture graspers may releasably secure the suture between twoor more surfaces by squeezing the surfaces together. In general, thesuture graspers such as the surfaces or jaws may be controlledautomatically or manually.

In another embodiment of tissue penetrator, the tissue penetrator 250may include a carabiner element which may secure the shuttle to thetissue penetrator. For example, the carabiner element pivots on one endand provides an opening on the opposite end, as illustrated in 44. Theshuttle 370, or alternatively, the suture 90, may interact with theflexible carabiner element to latch onto the tissue penetrator.Alternatively, one end of the carabiner element may pivot on an hinge,and thus the carabiner element may be rigid.

In some embodiments, there may be additional shuttle retention devices.For example, in FIGS. 46-48, a shuttle retention device may include apassive spring latch 52′ that is integral to the tissue penetrator. Forexample, the passive spring latch may be a small wire-formed or etchedspring steel part attached to the tissue penetrator 350 on the backsidein the groove for retaining pin clearance. Attachment may be, forexample, through welding, gluing, screwing, clipping, or the like.Further, spring latch 52′ may be part of tissue penetrator 350, whereinno attachment is necessary since spring latch 52′ is integral to tissuepenetrator 350. The shuttle retention may be assured with this snaplatch feature. This may allow relaxing tolerances on the shuttle andreduce engage/disengagement forces overall. The same retainer pin thatis alternately disposed in the shuttle's slot feature 274 to retain itin the lower jaw may still be used. Now, in this example, it may pushthe new latch beam spring part in distally, thereby releasing theshuttle from the tissue penetrator. As the tissue penetrator isretracted, the retainer pin 30 works as usual to retain the shuttle asit is pulled off the tissue penetrator.

One variation of this embodiment may be a leaf-spring member 52′ with atab/hook on the end which may be laser-welded to the tissue penetrator,and may form a clip that retains the shuttle. The retainer pin 30 wouldpress the tab to release the shuttle at the appropriate time.

Surgical Methods

All of the exemplary methods described herein are best performed withcontinuous suture passers having jaws that open and close whileremaining in an approximately parallel orientation (e.g., relative tothe upper and lower tissue-contacting surfaces of the jaws). Inaddition, the suture passer jaws may lock so that tissue can be securedbetween them, and the suture passed by means of a tissue penetrator thatcarries the suture, which may be attached to suture shuttle, between thetwo jaws. In particular, these methods may be performed using a devicethat is configured to pass the suture between the jaws regardless of theposition of the jaws relative to each other, and thus the jaws are notrequired to be in a particular position in order to pass the suturetherebetween. The following methods are examples only, the presentinvention is not limited to these explicitly recited examples but may beused in other similar surgical methods.

The present invention is capable of tying numerous types of suture knotsknown in the art including, but not limited to Modified Mason-Allenstitch, Figure-8 stitch, Margin Convergence Stitch, Incline MattressStitch, and Medial Row Modified Mason-Allen Stitch.

1. Medial or Lateral Meniscus Repair

An arthroscope may be inserted through a standard anteromedial oranterolateral portal and the knee joint is distended with saline instandard fashion. A posteromedial posterolateral portal site may becreated and the suture passing device may be placed into the joint. Thejaws of the suture passing device may open and be placed around theperipherally torn meniscus in such a fashion that the tear is spanned bythe jaws in an approximately perpendicular fashion as illustrated inFIG. 49. The meniscus capsule is slightly depressed by the capsularsided jaw to allow good purchase across the tear. The tissue penetratormay be, in one embodiment, passed from the first jaw to the second jawwith the suture. Alternatively, in another embodiment, the sutureshuttle may be passed across the meniscal tear via its reversibleattachment to the tissue penetrator, while the tissue penetrator is notreleased from the upper jaw. A knot may then be tied and the meniscushence repaired. An alternate design embodiment may allow passage ofsuture from the anteromedial or anterolateral portal, as illustrated inFIGS. 50A-D.

2. ACL Repair And Reefing

Standard anteromedial and anterolateral arthroscopic knee portals may beestablished and the camera and the suture passing device may be insertedinto the joint. The parallel jaws may be open and may be moved intoposition around the attenuated (post traumatically healed in anelongated state) anterior cruciate ligament, as is illustrated in FIG.51. The tissue penetrator may then be deployed from the first jaw tointeract with the second jaw, thereby passing the shuttle and/or sutureacross the ligament. The distal end of the suture passer may then bemoved to a different position on the ligament and the shuttle and/orsuture may then be passed back from the second jaw to the first, therebycontacting the tissue penetrator once again. The suture may be tied byalternating the suture end between the jaws in standard knot tyingfashion. The procedure is repeated until the ACL is of the appropriatelength and tension.

3. Medial Patellofemoral Ligament Reefing

The arthroscope may be inserted through a standard inferolateral portaland the knee joint is distended with saline in standard fashion. Theinferomedial portal is then created and the suture passing device may beinserted into the patellofemoral joint space. The attenuated medialpatellofemoral ligament is identified. Sutures may be arthroscopicallyplaced across the length of the ligament with the suture passing devicealternating the shuttle and/or suture between the first and second jaws.Knots may be tied with the device by placing the free end of suturebetween the jaws and passing the shuttle and/or suture from the first tothe second jaw. This may be repeated after moving the jaws into standardsimple knot forming positions and the knot is cinched by moving thedistal end of the passer away from the suture site while holding tensionon the opposite suture limb. This may be repeated until about 3-4hitches are placed, and then the free ends are cut. This process may berepeated as necessary until the ligament is shortened, reefed,imbricated, or the like to the desired length and tension. Lateralpatellar glide is then checked and confirmed to be decreased.

4. Medial Patellofemoral Ligament Repair

The arthroscope may be inserted through a standard inferolateral portaland the knee joint is distended with saline in standard fashion. Theinferomedial portal is then created and the suture passing device may beinserted into patellofemoral joint space. The edges of the torn medialpatellofemoral ligament are identified and the suture passer jaws may beapproximated around the medial aspect of the torn leading edge of theligament. A horizontal mattress or simple type suture pattern, forexample, may be passed arthroscopically with the suture passer device bypassing the shuttle and/or suture from the first jaw to the second jaw.The lateral leading edge of the torn medial patellofemoral ligament isthen identified and the device may be used to pass the shuttle and/orsuture from the second jaw back to the first jaw, and the knot is tiedto secure the repair. This process may be repeated until the two ends ofthe ruptured ligament are reapproximated and hence repaired.

5. Minimally Invasive Achilles Tendon Repair

An about 1-2 cm transverse or vertical incision, for example, may bemade in close approximation to the site of rupture of the Achillestendon. The peritendon is identified and separated from the torn tendon.The edges of the tear are debrided and prepared in standard fashion. Theskin and soft tissues may be gently retracted to allow insertion of thesuture passing device. The suture passer may be slid underneath theperitendon and the jaws are opened and approximated around the leadingedge of the proximal stump of the torn Achilles tendon, as illustratedin FIG. 52. A horizontal mattress or simple type suture pattern, forexample, may be passed with the suture passer device by passing theshuttle and/or suture from the first jaw to the second jaw, moving to analternate location on the same tendon fragment, and then passing fromsecond jaw to first jaw. This process is repeated on the distal tendonstump. The two ends of the ruptured ligament are then reapproximated bytying the placed sutures together at the rupture site.

6. Superior Labrum Anterior Posterior Repair

A posterior shoulder portal may be created for camera placement instandard fashion. A standard anterior portal may be made just superiorto the subscapularis tendon and an about 8 mm cannula is placed into theshoulder joint. A standard labral repair suture anchor is placed intothe superior glenoid rim in the appropriate position for the repair. Onelimb of the suture is then brought out of the anterior portal with acrochet hook. The suture passer device may then be loaded with the freeend of the suture and inserted through the cannula. The jaws areapproximated around the superior labral tear as depicted in FIGS. 53A-C.The suture may then be passed from the first jaw to the second jaw. Thesuture may then either be tied using the suture passer by alternatingthe shuttle and/or suture between the jaws or it can be tied usingstandard sliding knots and a knot pusher.

7. Arthroscopic Bankart Repair and Capsular Shift for GlenohumeralLabral Repair Anterior Inferior or Posterior Inferior

Standard shoulder arthroscopy portals may be created and the suturepasser device may be inserted into the glenohumeral joint. A sutureanchor may be placed at either the 7 or 5 o'clock position on theglenoid rim. One limb of suture from this anchor may then be brought outthrough a cannula and loaded into the suture passer device. The unstableinferior labral tissue and capacious capsule may be grasped by thesuture passer device and the tissue penetrator may then be deployedsending the shuttle and/or suture through the desired tissue from thefirst jaw to the second jaw, as illustrated in FIG. 54. The suture isthen tied to the other suture limb in standard labral repair fashion.

8. Arthroscopic Biceps Tenodesis

A standard shoulder arthroscopy is performed. The jaws of the suturepasser may be placed around the biceps tendon and the shuttle and/orsuture is passed back and forth across the tendon. The biceps is thencut from its superior labral attachment and tenodesed in standardfashion.

9. Arthroscopic Hip Labral Repair

Standard hip arthroscopy portals are created. The hip labral tear isevaluated and a portal may be created to maximize positioning of thecannula for insertion of the suture passer. A suture anchor is placed inthe acetabular rim at the level of the labral tear in standard fashion.The passer may be loaded with a free end from the anchor and the jawsmay be placed around the torn labrum. The shuttle and/or suture may bepassed from the first jaw to the second jaw through the labral tissue.The suture ends are tied in standard fashion.

10. Arthoroscopic Brostrom for Ankle Ligament Instability

Standard ankle arthroscopy portals are created. The suture passer devicemay be inserted into the ankle joint and the attenuated lateral anklecapsule and calcaneofibular ligament are identified. Multiple suturesmay then be passed through the ligament and capsule by alternating theshuttle and/or suture from the first jaw to the second jaw and back tothe first, as necessary. As standard knots may be tied the CFL andcapacious capsule are tightened to the appropriate tension and thelateral ankle hence stabilized.

11. Arthroscopic Triangular Fibrocartilagenous Complex Repair (TFCCRepair)

Standard wrist arthroscopy portals are created and the arthroscope maybe inserted into the wrist and directed toward the ulnar side. Asmall-sized embodiment of the suture passer device may then be insertedinto the wrist joint. The tear in the TFCC may then be grasped with thesuture passer device and suture may be passed from the first to thesecond jaw. The distal end of the passer may then be moved to surroundthe opposite side of the TFCC tear and the tissue penetrator may againbe deployed, this time sending the suture from the second jaw to thefirst. The suture is tied in standard arthroscopic knot tying fashion.This pattern is repeated until the TFCC tear is completely repaired.

12. Medial Row Modified Masson-Allen Double Row Rotator Cuff Repair

Standard shoulder arthroscopy portals are created and the camera isinserted into the subacromial space. A standard subacromialdecompression is performed. A suture anchor may then be placed at themedial aspect of the greater tuberosity in close proximity to thehumeral head cartilaginous surface. One limb of suture from the anchormay then be loaded into the suture passer device and the device may beinserted into the joint. The jaws may be placed around the leading edgeof the rotator cuff tear and the tissue penetrator may be deployed tosend the shuttle and/or suture from the first jaw to the second jaw.This passed suture end is then removed from the subacromial spacethrough an anterior portal, illustrated in FIG. 55A. The suture passerdevice may then be loaded with the other suture strand from the medialrow anchor and the device is reinserted into the subacromial space. Thejaws may again be approximated around the leading edge of the tornrotator cuff tendon and the suture is passed from the first jaw to thesecond jaw, as in FIG. 55B. The distal end of the suture passer devicemay then be moved to the right or left and the tissue penetrator may bere-deployed to send the suture from the second jaw to the first, asillustrated in FIG. 55C. The distal end of the suture passer device maythen be moved into a position that is medial to and in between theprevious passes and the suture may again be passed from the first jaw tothe second jaw, as in FIG. 55D. The knot may be tied using the suturepasser device or using standard knot tying techniques, as thoseillustrated in FIGS. 55E and 56A. The two strands of remaining suturefrom the tied knot may then be brought laterally and tied down to alateral row knotless anchor using standard techniques, such as those inFIGS. 56B-C.

13. Spinal Surgery

Dural tears are a common complication during spine surgery. Ifimproperly closed they can lead to the development of dural-cutaneousfistulas, pseudomeningocele, and meningitis. Dural tear that arediscovered or caused intraoperatively are best treated by direct repair,a fascial graft, or both.

Annular incisions are commonly made during microdiscectomy to allowaccess to the nuclear material. The annular incision is uncommonlyclosed secondary to difficulty manipulating suture and the tissuepenetrator in this space. Sewing the annular incision would likelydecrease recurrence rates of disc herniation. Thus a continuous suturepasser would be useful to repair this incision.

A standard microdiscectomy posterior approach to the spine is performed.As FIGS. 57-58 illustrate, the jaws of the suture passer device may beplaced around the dura (or annulas) at one side of the tear. The suturemay be passed from the first jaw to the second jaw. The jaws may then bepositioned around the contralateral side of the tear, and the suture maybe passed from the second jaw to the first jaw. A standard knot may thenbe tied. The procedure may be repeated until the tear is completelyrepaired.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. A continuous suture passer device comprising: a first jaw and asecond jaw; a tissue penetrator to penetrate through tissue positionedbetween the first and second jaws; a suture shuttle releasably securedto the tissue penetrator and adapted to carry a suture; and an actuatorto manipulate at least one of the first or second jaws and the tissuepenetrator, the second jaw having a suture shuttle retainer seat onwhich the suture shuttle can be releasably secured, the tissuepenetrator being movable towards the second jaw such that the sutureshuttle carried by the tissue penetrator can be transferred to theshuttle retainer seat on the second jaw.
 2. The continuous suture passerdevice of claim 1, wherein the first and second jaws are substantiallyparallel to one another at any position to which the at least one jaw ismanipulated.
 3. The continuous suture passer device of claim 1, whereinthe tissue penetrator travels along an arcuate path from a firstposition, recessed within the first jaw, to a second position where thetissue penetrator extends through tissue to be positioned incommunication with the second jaw.
 4. The continuous suture passerdevice of claim 3, wherein the suture shuttle is passed from the tissuepenetrator to the shuttle retainer seat when the tissue penetrator is incommunication with the second jaw.
 5. The continuous suture passerdevice of claim 4, wherein the shuttle retainer seat in the second jawis moveable in at least one direction, including rotationally within theposition of the shuttle retainer seat in the second jaw andlongitudinally planar along an axis of the second jaw.
 6. The continuoussuture passer device of claim 3, wherein the actuator manipulates thesecond jaw, wherein the second jaw comprises a pivot arm which isslidable along a shaft of the suture passer device such that the secondjaw travels along a path that is substantially the same arcuate pathtraveled by the tissue penetrator and the first and second jaws remainsubstantially parallel at any position to which the second jaw ismanipulated.
 7. The continuous suture passer device of claim 6, whereinthe second jaw further comprises a retainer pin, wherein the retainerpin remains in a constant engagement depth within the shuttle retainerseat irrespective of where the at least one jaw is manipulated.
 8. Thecontinuous suture passer device of claim 7, wherein the suture retainerseat further comprises a seat radius which interacts with tissuepenetrator such that the seat radius allows shuttle retainer seat toreturn to a single position once tissue penetrator exits the second jaw.9. The continuous suture passer device of claim 1, wherein the sutureshuttle comprises a multi-sided body, whose form approximates across-section of the tissue penetrator, with an interior to receive thetissue penetrator.
 10. The continuous suture passer device of claim 9,wherein the tissue penetrator further comprises a recessed portion onwhich the suture shuttle may be at least partially received.
 11. Thecontinuous suture passer device of claim 10, wherein the suture shuttlefurther comprises at least one retention mechanism which engages thetissue penetrator.
 12. The continuous suture passer device of claim 11,wherein the retention mechanism is a dimple which engages a divot on thetissue penetrator.
 13. The continuous suture passer device of claim 1wherein the actuator comprises a handle.
 14. A continuous suture passerdevice comprising: a first jaw and a second jaw; an actuator including ajaw control to manipulate at least one jaw; and a tissue penetratorconfigured to travel along an arcuate pathway from the first jaw to thesecond jaw; wherein the first and second jaws are substantially parallelto one another at any position to which the at least one jaw ismanipulated, and wherein the at least one jaw travels along a path thatis substantially the same arcuate path traveled by the tissuepenetrator.
 15. The continuous suture passer device of claim 14, whereina suture shuttle carrying a suture may be passed between the tissuepenetrator and the second jaw, wherein the suture shuttle may bereleasably secured to either of the tissue penetrator and the secondjaw.
 16. The continuous suture passer device of claim 15, wherein thesecond jaw further comprises a shuttle retainer seat which communicateswith the tissue penetrator and receives at least a portion of the sutureshuttle from the tissue penetrator.
 17. The continuous suture passerdevice of claim 16, wherein the shuttle retainer seat is moveable in atleast one direction including rotationally within the position of theshuttle retainer seat in the second jaw and longitudinally planar alongan axis of the second jaw.
 18. The continuous suture passer device ofclaim 14, wherein the second jaw further comprises a pivot arm, whereinthe pivot arm is slidable along a shaft of the suture passer device. 19.The continuous suture passer device of claim 14, wherein the sutureshuttle comprises a multi-sided body, whose form approximates across-section of the tissue penetrator, with an interior to receive thetissue penetrator.
 20. The continuous suture passer device of claim 19,wherein the tissue penetrator further comprises a recessed portion onwhich the suture shuttle may be at least partially received.
 21. Thecontinuous suture passer device of claim 20, wherein the suture shuttlefurther comprises at least one retention mechanism which engages thetissue penetrator.
 22. The continuous suture passer device of claim 21,wherein the retention mechanism is a dimple which engages a divot on thetissue penetrator.
 23. The continuous suture passer device of claim 14wherein the actuator comprises a handle.
 24. The continuous suturepasser device of claim 14, wherein the second jaw further comprises aretainer pin, wherein the retainer pin remains in a constant engagementdepth within the shuttle retainer seat irrespective of where the atleast one jaw is manipulated.